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Design Quality Engineers NEEDED - Raynham, MA

Kelly Services


Location:
Raynham, MA
Date:
04/25/2018
2018-04-252018-05-24
Job Code:
US41JYKS_BH1435720
Categories:
  • Engineering
Kelly Services
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Job Details

Job Title Design Quality Engineers NEEDED - Raynham, MA

Jobid US41JYKS_BH1435720

Location: Raynham, MA, 02767, USA

Description Kelly Services is currently looking to hire three **_Design Quality Engineers_** for our client, a leader in the medical device industry, at their site in Raynham, MA. Chosen candidates should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. Candidates will support efforts to ensure EU Medical Device Regulation compliance and must have a strong compliance background and experience with Medical Device Regulations. These are long term contract (approved through 2020) opportunities offered through our KellyOCG group which includes benefits such as PTO, paid sick time, and 401k contribution. Please review our Qualifications below and APPLY NOW if interested!

**RESPONSIBILITIES** :


+ Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
+ Review and approve design documentation including Verification & Validation rationales, risk documents (design and process), standards evaluations, mechanical test protocols and reports.
+ Support risk management activities including planning, design & clinical risk management DFMEA, production risk management PFMEA, and overall risk summary reporting.
+ Revise, review and approve verification and validation activities as required.
+ Review and approve any required drawing updates, including design impact assessments.
+ Review and approve any labeling updates, including design impact assessments.
+ Deliverables to be quarterly based on assigned files.
+ Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
+ Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.
+ Provide leadership in the understanding of medical device regulations to other disciplines.
+ Ability to work in a team setting within Design Quality and cross-functionally is required.
+ Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and rketing.
+ Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
+ Report task progress and status on a weekly basis.
QUALIFICATIONS:


+ A minimum of Bachelor's degree in engineering or related technical or scientific discipline with a minimum of 5 years of experience in related field are required.
+ Strong design/quality engineering skills with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management are required.
+ Proven track record implementing Quality System improvements to meet compliance and overall business goals.
+ Change control experience (reviewing and approving design engineering change orders through a PLM System) is required
+ Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.) is required.
+ Candidate should possess excellent problem solving, decision-making, and root-cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
+ Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
+ Working knowledge of Design Controls, GMPs, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is preferred.
+ Previous experience in a medical device or a healthcare discipline is preferred.
+ Previous Quality Engineering experience is preferred.
+ Working knowledge of material science and mechanical product knowledge is preferred.
+ Development and/or manufacturing experience is preferred.
+ Blueprint literacy including GD&T is preferred.
+ Knowledge of process and design excellence tools is preferred.
+ This position will be based in Raynham, MA
**Why Kelly** **®** **?**


Kelly puts you in charge of your career, with access to cutting edge projects and technologies inindustry leading organizations. Top companies throughout the world have trusted Kelly as a premiersource of engineering talent and services since 1965. And engineering job seekers know Kelly as a firmwith an unmatched reputation for quality, integrity and professionalism. Whether you seek the varietyand flexibility of working on short term project engagements, or prefer contract-to-hire or directhire placement with our clients, apply with Kelly to explore opportunities that suit your specificprofessional interests.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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